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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS
Classification Namestent, coronary
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS218
Date Received12/21/2004
Decision Date01/14/2005
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change to allow sterile product release based on demonstration of conformity to pre-defined sterilization parameters (parametric release) rather than release based on demonstrating no growth of biological indicators (conventional release).
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